Status:
COMPLETED
Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers
Lead Sponsor:
University of Colorado, Denver
Conditions:
Hepatitis C
HIV
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. The investigators believe that etravirine's drug concentrations will b...
Detailed Description
To investigate the potential for drug interactions between boceprevir and etravirine, participants will receive each drug alone and the drugs in combination for 11-14 days. The pharmacokinetics of boc...
Eligibility Criteria
Inclusion
- Men and women ages 18-60 years
- Absence of HIV-1 and HCV antibodies at screening
- Ability and willingness to give written informed consent before the first trial-related activity
Exclusion
- Pregnancy
- Breastfeeding
- Active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements.
- Participation in any investigation drug study within 30 days prior to study.
- Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results.
- Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions:aspirin, acetaminophen, once daily multivitamins, mineral supplements and hormonal oral contraceptives (other than those that contain drospirenone). Concomitant medications other than those listed above must have been discontinued at least 14 days before study entry.
- Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis.
- History of significant drug allergy (i.e., anaphylaxis and/or angioedema)
- Subjects with the following laboratory abnormalities at screening as defined by the 2004 Division of AIDS Table for grading the Severity of Adult and Pediatric Adverse Events and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (\>1.1 x upper limit of laboratory normal range (ULN); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x ULN), any other laboratory abnormality of grade 2 or above
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01427504
Start Date
August 1 2011
End Date
March 1 2012
Last Update
July 9 2013
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045